Coping Skills Training for Anxiety and Stress

(Blueprint 2 Trial)

Overseen By Kristy Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Active substance abuse, Severe mental illness, Complex medical needs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mobile app called Blueprint, designed to help people manage anxiety and stress after serious health issues like heart failure or severe COVID pneumonia. The app teaches coping skills to improve mental health and quality of life, particularly for those recently in intensive care. Participants will use either the Blueprint app or an educational app for comparison. Individuals who were in intensive care with serious heart or lung problems and feel anxious or stressed might be a good fit for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance mental well-being after intensive care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for coping skills, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

What prior data suggests that the Blueprint mobile app is safe for improving mental health symptoms?

Research has shown that the Blueprint mobile app is generally safe for users. In a previous study, participants using Blueprint experienced less depression and improved quality of life compared to those using a placebo app. Importantly, the study reported no serious side effects, suggesting the app is well-tolerated for its intended use.

Developed and refined over many years, the Blueprint app helps patients manage stress and anxiety after ICU stays. It is easy to use and aims to teach coping skills through a month-long program. While further research is needed to confirm these findings, early results are promising for its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blueprint adaptive coping skills intervention because it offers a personalized approach through a mobile app specifically targeting anxiety and stress in patients with cardiorespiratory conditions. Unlike traditional methods that might involve general therapy or medication, Blueprint provides tailored content delivered weekly, ensuring it adapts to individual needs. This innovative delivery method not only makes it more accessible but also includes safety monitoring through in-app surveys, enhancing patient engagement and potentially leading to better outcomes.

What evidence suggests that the Blueprint mobile app is effective for anxiety and stress?

Research has shown that the Blueprint app, which teaches coping skills, delivers promising results. In this trial, participants in one arm will use the Blueprint app, which earlier studies have shown helps users feel less depressed and improves their quality of life compared to those using a placebo app. The app is user-friendly and offers various content types, such as audio, video, and text, over four weeks to aid in managing mental health. This approach aims to make mental health care more accessible, especially for those who cannot easily access traditional services. Overall, early findings suggest Blueprint could be a helpful tool for people recovering from ICU care and dealing with anxiety or stress. ^{4 5 6 7 8}

Who Is on the Research Team?

Christopher Cox

Principal Investigator

Professor of Medicine

Are You a Good Fit for This Trial?

This trial is for survivors of cardiorespiratory failure who have been in the ICU and are experiencing psychological distress such as depression, anxiety, or PTSD. It's particularly focused on including patients from racially and ethnically minoritized groups.

Inclusion Criteria

My thinking and memory skills are functioning well.

I was in intensive care or a similar unit for at least 24 hours recently.

I do not have a severe heart or lung condition.

Exclusion Criteria

Active alcohol or drug abuse meeting specific criteria

Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up

Other complex needs anticipated that could interfere with the ability to complete study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Blueprint mobile app or an Education Program mobile app for 4 weeks

4 weeks

Weekly app sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 1, 3, and 6 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Blueprint
• Education program

Trial Overview

The study tests a mobile app called Blueprint that teaches adaptive coping skills to manage symptoms against an Education Program app. Both apps aim to improve mental health over six months, with participants randomly assigned to one of the two.

How Is the Trial Designed?

Group I: Blueprint adaptive coping skills intervention Experimental Treatment 1 Intervention

This is a unique adaptive coping skills intervention developed over years of research that targets patients hospitalized for cardiorespiratory conditions. Participants will receive 4 weeks of different Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.

Group II: Education program control Active Control 1 Intervention

This is cardiorespiratory condition-specific content through an iterative process, informed by research on informational needs and past successful education programs. Participants will receive 4 weeks of different 10-minute informational videos unrelated to Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A 5-week video-based slow diaphragmatic breathing curriculum for high school students was found to be feasible and tolerable, with students generally enjoying the exercises despite some challenges with extended exhales.

Preliminary effectiveness assessments showed no significant changes in anxiety levels or physiological stress responses, suggesting that while the program was well-received, it may need adjustments to improve its impact on anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-Breathing Curriculum for Stress Reduction in High School Students: Lessons Learned From a Feasibility Pilot. Bentley, TGK., Seeber, C., Hightower, E., et al.[2022]

Camp Cope-A-Lot (CCAL), a computer-assisted cognitive behavioral therapy for anxiety, was found to be effective, with 81% of participants no longer meeting criteria for their anxiety diagnosis after treatment, similar to individual CBT results.

Both CCAL and individual CBT were rated as more acceptable and satisfying by children and parents compared to a control group receiving computer-assisted education, indicating strong potential for using technology in treating youth anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. Khanna, MS., Kendall, PC.[2022]

The AST study demonstrated that both the EnergyPod™ and SleepWing™ devices significantly improved mood among high school students, as measured by the Profile of Mood States-Short Form, with a notable reduction in Total Mood Disturbance (p < .001).

Regardless of which device was used, all participants showed significant improvements across various mood subscales, indicating that both devices are effective tools for stress reduction in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent Stress Treatment Study: A Cluster Randomized Trial. Lynch, S., DeBlieck, C., Summers, LC., et al.[2020]

The Positive Technology app, designed for self-management of psychological stress, includes guided relaxation, 3D biofeedback, and stress tracking, showing promise in reducing perceived stress levels based on user feedback from a trial with 32 participants.

Participants reported satisfactory experiences with the app, and those using it with a wrist sensor demonstrated enhanced capabilities for monitoring and managing stress, indicating potential for further development in usability and advanced features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. Gaggioli, A., Cipresso, P., Serino, S., et al.[2018]

The Coping Course, a cognitive-behavioral group intervention for incarcerated youth, showed significant improvements in various measures of coping and problem-solving skills among 76 male adolescents, indicating its potential effectiveness.

Participants in the Coping Course demonstrated unique positive changes compared to control groups, suggesting that the intervention specifically contributed to improvements in self-esteem, social adjustment, and knowledge of cognitive-behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of the Coping Course: a cognitive-behavioral intervention to enhance coping skills in incarcerated youth. Rohde, P., Jorgensen, JS., Seeley, JR., et al.[2018]

An 8-week stress management program significantly reduced the waist-hip ratio in obese Greek children and adolescents, indicating improved body composition.

The intervention also led to better school performance and healthier daily habits among participants, although it did not significantly affect BMI, stress, anxiety, or cortisol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents. Emmanouil, CC., Pervanidou, P., Charmandari, E., et al.[2019]

A 6-week mindfulness-based coping-enhancement program for 208 first-year college students significantly improved their stress management, emotion regulation, and overall well-being, as compared to those who had not yet participated.

The positive effects, including increased mindfulness and resilience, were largely maintained three months after completing the program, indicating its potential long-term benefits for college students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based promotive coping program improves well-being in college undergraduates. Long, R., Halvorson, M., Lengua, LJ.[2021]

The Coping Camp app significantly reduced perceived stress, anxiety, and depression among 540 high school students in China over an 11-week intervention, demonstrating its efficacy in managing mental health issues.

Participants found the app to be feasible and acceptable, with high engagement rates (75.4% post-intervention attendance) and positive qualitative feedback, indicating it was viewed as a useful tool for stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability and efficacy of an app-based intervention (the Coping Camp) in reducing stress among Chinese school adolescents: A cluster randomised controlled trial. Zhou, X., Edirippulige, S., Jones, A., et al.[2023]

The 'Learn Young, Learn Fair' program, implemented in a study with 1,467 fifth and sixth graders across 52 schools, significantly reduced stress symptoms and anxiety, highlighting its efficacy as a universal stress management intervention.

The program improved emotion-focused coping and stress awareness among children, suggesting that school-based prevention programs can effectively address stress-related issues in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Learn Young, Learn Fair', a stress management program for fifth and sixth graders: longitudinal results from an experimental study. Kraag, G., Van Breukelen, GJ., Kok, G., et al.[2009]

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